MAUDE Adverse Event Report: ARTHREX, INC. SUTURELASSO, 45 DEGREE CURVE RIGHT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	SUTURELASSO, 45 DEGREE CURVE RIGHT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 27th january 2025, it was reported by an arthrex employee via email that for an ar-4068-45r, suturelasso¿ sd, 45° curve right, the tip of the lasso broke inside patient.This was detected during use in an arthroscopic shoulder bankart and slap repair procedure on (b)(6) 2025.Tip was recovered but had to create a big portal to get it out and delayed the procedure for another 30 minutes.The procedure was completed successfully and the repair was done successfully.
Additional Manufacturer Narrative
The complaint allegation is confirmed based on the image received from the field.The photos submitted for evaluation depict the distal tip of the device broken off.Consequently, arthrex was able to conclude a most likely cause as the device wasn't returned for evaluation.The most likely cause for the reported failure can be attributed to misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: SUTURELASSO, 45 DEGREE CURVE RIGHT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 21344047
• Report Number: 1220246-2025-00328
• Device Sequence Number: 20797044
• Product Code: LXH
• UDI-Device Identifier: 00888867031494
• UDI-Public: (01)00888867031494(11)240601(17)290531(10)4164150054
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SUTURELASSO, 45 DEGREE CURVE RIGHT
• Device Catalogue Number: AR-4068-45R
• Device Lot Number: 4164150054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown